Dorzostill 20 mg/ml, oogdruppels, oplossing

Dorzostill is an ophthalmic product (eye drops) containing dorzolamide, which belongs to the group of medicinal products called carbonic anhydrase inhibitors.

The eye drops are used for the reduction of increased pressure in the eye and to treat glaucoma. The drops can be used either alone or with other eye drops which lower pressure in the eye (so-called beta-blockers).

Do not use Dorzostill

• if you are allergic (hypersensitive) to any of the ingredients of Dorzostill
• if you have severe kidney problems
• if you have a disturbance in the pH (acid/alkali balance) of your blood

Take special care with Dorzostill

Before using Dorzostill you should tell your doctor (or pharmacist) if:

• you have or have had liver problems in the past
• If you have or have had in the past kidney stones
• you have been told you have a corneal defect
• you have had any allergies to any medicines
• you have had, or are about to have eye surgery
• you have suffered an eye injury or have an eye infection
• you wear contact lenses (see section ‘Important information about some of the ingredients of Dorzostill below).

You should contact your doctor immediately if you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the surface layer of the eye or eyelids.

Stop using Dorzostill and contact your doctor immediately if you suspect that Dorzostill is causing an allergic reaction (for example, skin rash or itching).

Children

Dorzolamide has been studied in infants and children who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.

Elderly

Dorzolamide has been shown to have the same effects in elderly patients as in younger.

Using other medicines

Please tell your doctor if you recently have used, are using or plan to use any other medicines, including other eye drops or medicines obtained without a prescription, particularly if you are taking large doses of painkillers containing salicylic acid (e.g. aspirin). Although there is no evidence that Dorzostill interacts with painkillers containing salicylic acid , some other medicines which are related to Dorzostill and which are taken by mouth, have been known to interact with painkillers containing salicylic acid .

You should also tell your doctor if you are taking another carbonic anhydrase inhibitor such as acetazolamide.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

If you are pregnant or likely to be pregnant, you should not use Dorzostill.

These eye drops should not be used while breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Possible side effects of Dorzostill such as dizziness and visual disturbances may affect your ability to drive or operate machinery. If you experience such side-effects, you should not drive or operate machinery.

Important information about some of the ingredients of Dorzostill

Dorzostill contains the preservative benzalkonium chloride, which may cause eye irritation. This preservative may be deposited in soft contact lenses and may possibly discolour the lenses. If you wear soft contact lenses, you should consult your doctor before using Dorzostill. It is important that your lenses are removed before using your eye drops and not put back into your eyes until 15 minutes after using your eye drops.

Always use Dorzostill exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage and frequency of administration

When Dorzostill is used alone, the usual dose is one drop in the affected eye(s) three times a day, for example in the morning, in the afternoon and in the evening.

If your doctor has recommended you use Dorzostill with a beta-blocker eye drop to lower eye pressure, then the usual dose is one drop of Dorzostill in the affected eye(s) two times a day, for example in the morning and in the evening.

If you are using Dorzostill with another eye drop, the drops should be instilled at least 10 minutes apart. Alternatively if you are going to use Dorzostill to replace another eye drop medicine, used to lower eye pressure, you should stop using the other medicine after taking the proper dosing on one day, and start Dorzostill on the next day.

Do not change the dosage of the drug without consulting your doctor and ask your doctor or pharmacist explain anything that you do not understand. If you must stop the treatment, contact your doctor immediately.

Instructions for use

Dorzostill is intended for ocular use.

Do not allow the tip of the container to touch your eye or areas around your eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.

Always wash your hands before putting in your eye drops.

1. To open the bottle unscrew the cap.
2. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
3. Squeeze lightly the upturned dropper bottle until a single drop is dispensed into the eye. Do not touch the eye, eye lid or anything else with the dropper tip. Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.
4. Repeat steps 2 & 3 with the other eye if instructed to do so by your doctor.

Replace the cap immediately after use by screwing down until it is firmly touching the bottle. Do not over- tighten the cap.

The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip. After you have used all doses, there will be some Dorzostill left in the bottle. You should not be concerned since an extra amount of Dorzostill has been added and you will get the full amount of Dorzostill that your doctor prescribed. Do not attempt to remove the excess medicine from the bottle.

If you use more Dorzostill than you should

If you put too many drops in your eye or swallow any of the contents, you should contact your doctor immediately. Symptoms include sleepiness in case you have swallowed Dorzostill and nausea, dizziness, headache, tiredness, fatigue, abnormal dreams and difficulty in swallowing after application of too many drops in the eyes.

If you forget to use Dorzostill

It is important to take Dorzostill as prescribed by your doctor. If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.

If you stop using Dorzostill

If you must stop treatment, contact your doctor immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Dorzostill can cause side effects, although not everybody gets them. The potential side effects of Dorzostill may include:

Very common: more than 1 in 10 patients

Effects on the eye(s): burning and stinging

Common: less than 1 in 10, but more than 1 in 100 patients

Effects on the eye(s): sensitivity to light and pain in the eye resulting from inflammation of the front part of the eye (keratitis), inflammation of the conjunctiva, effects on the surface of the eye, watering or itching of the eye(s), inflammation or irritation of the eyelid(s) and/or skin around the eye(s), blurred vision.

Effects on other parts of the body: headache, nausea, tiredness, bitter taste in the mouth after application of the eye drops.

Uncommon: less than 1 in 100, but more than 1 in 1000 patients

Effects on the eye(s): inflammation of the coloured part of the eye

Rare: less than 1 in 1000, but more than 1 in 10,000 patients

Effects on the eye(s): irritation and redness of the eye(s), eye pain, swelling of the surface layer of the eye(s), crusting of the eyelid(s), temporary short-sightedness (which stops when the medicine is discontinued), choroidal detachment which may be accompanied by visual changes/disturbances (following eye surgery).

Effects on other parts of the body: dizziness, numbness/tingling sensation, nose bleed, dry mouth, throat irritation, allergic reactions including rash, hives, itching, possible swelling of the lips, eyes and mouth, shortness of breath and kidney stones.

Please tell your doctor (or pharmacist) promptly about these or any other unusual symptoms, particularly if you experience any visual changes/disturbances when using Dorzostill after eye surgery.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not use Dorzostill after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.

Do not use Dorzostill later than 30 days after first opening. Open a new bottle after 30 days even if there is some Dorzostill left in the old bottle.

Store the unopened bottle below 30°C. Store the bottle after first opening below 25°C. Always keep the bottle in the outer carton to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Dorzostill contains

• The active substance is dorzolamide. Each ml contains 20.0 mg dorzolamide (as 22.3 mg dorzolamide hydrochloride).
• The other ingredients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide/hydrochloride acid (for pH adjustment), benzalkonium chloride (preservative) and purified water.

What Dorzostill looks like and contents of the pack

Dorzostill is clear or slightly opalescent, colourless, isotonic, buffered, slightly viscous aqueous eye drop solution free from visible particles. It is available in sterile bottles with a dropper and cap made of plastic. Each bottle contains 5 ml solution.

The bottles are packed in cartons of 1 x 5 ml (single bottle) or 3 x 5 ml (pack containing 3 bottles) or 6x 5ml (pack containing 6 bottles). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[Name of the Member State /Name of the medicinal product to be completed nationally] [Name of the Member State /Name of the medicinal product to be completed nationally]

This leaflet was last approved in MM/YYYY [To be completed nationally]